Kornimate/medical-research-clean huggingface dataset:
comparison of intraocular pressure (iop)-lowering efficacy and safety of azorga® ophthalmic suspension and cosopt® ophthalmic solution

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate azorga® ophthalmic suspension compared to cosopt® ophthalmic solution for iop-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

after the screening examination, subjects were enrolled in the study and moved into the observation period. during the observation period, prostaglandin-analog (pga) monotherapy was applied. after the observation period of 4 weeks or more, the baseline examination was performed. subjects were then randomized and moved into the treatment period.

Eligibility criteria:
inclusion criteria: * understand the nature of the study and sign informed consent. * diagnosis of open angle glaucoma or ocular hypertension. * currently on pga monotherapy or pga + alpha-1/beta blocker or pga + alpha-2 agonist at screening visit, and allowed to instill only pga for 4 weeks until the baseline visit. * intraocular pressure (iop) ≥ 15 mmhg (at least one same eye) at the baseline visit. * other protocol-specified inclusion criteria may apply. exclusion criteria: * history of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease. * uncontrolled heart failure, sinus bradycardia, a-v block (ii, iii grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure. * history of hypersensitivity to any of the excipients of the study medications. * severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders. * corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye. * history of ocular trauma in either eye within 6 months prior to the screening examination. * ocular infection or ocular inflammation in either eye. * history of or current clinically significant or progressive retinal disease in either eye. * intraocular surgery in either eye within 6 months prior to the screening examination. * ocular laser surgery in either eye within 3 months prior to the screening examination. * any abnormality preventing reliable applanation tonometry of either eye. * best-corrected visual acuity (bcva) worse than 0.2 score (decimal visual acuity) in either eye. * severe visual field loss in either eye. * use of prohibited medication, as specified in the protocol. * pregnant, lactating, or intending to become pregnant during the study period. * currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination. * history of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study. * other protocol-specified exclusion criteria may apply.

Keywords: open-angle glaucoma (oag) ocular hypertension (oht) azorga® cosopt®
mrs and 11c-methionine pet/ct in the diagnosis of glioma

Conditions: Glioma

Summary: met pet and mrs are often performed as imaging tool for the differential diagnosis of gliomas. but both techniques have limitations causing misdiagnosis; thus, the investigators tried to combine these two imaging tools to study whether the combination of met pet and mrs could raise the diagnosis ability of the radiological diagnosis of gliomas.


Eligibility criteria:
inclusion criteria: 1. patients with non-enhancing supratentorial lesions shown by contrast-enhanced mri 2. no surgery, chemotherapy or radiotherapy history 3. all patients gave written informed consent. exclusion criteria: 1. patients with infratentorial neoplasms 2. patients with enhancing supratentorial lesions 3. recurrent gliomas after surgery 4. primary gliomas with history of radiotherapy or chemotherapy 5. history of malignant tumours at any body site 6. inability to give informed consent

Keywords: glioma magnetic resonance spectroscopy methionine pet/ct
comparing quality of recovery between espb and iv lidocaine after major breast cancer surgery

Conditions: Breast Neoplasms

Summary: the erector spinae plane block (espb) is gaining popularity as a regional anesthetic technique for major breast cancer surgery. although there is controversy about its mechanism of action, emerging evidence suggests that clinical analgesia observed after espb in breast surgery may be due to rapid and sustained local anesthetic absorption from the injection site. hence intravenous la infusion (ivli) during the perioperative period could offer an effective alternative to invasive espb.

major breast cancer surgery (bcs), including mastectomy or modified radical mastectomy (mrm), is a globally prevalent procedure. unfortunately, it is associated not only with significant acute postoperative pain but also a high incidence of chronic postsurgical pain (30-50%) . to improve outcomes, regional anesthetic techniques have been explored, including thoracic paravertebral block (tpvb) and ultrasound-guided erector spinae plane block (espb). while tpvb is considered the gold standard, it carries potential complications such as pleural puncture and pneumothorax. in contrast, ultrasound-guided (usg) espb is gaining popularity due to its technical simplicity and safety. however, controversy surrounds its mechanism of action, particularly the variable cutaneous sensory loss over anterior thoracic dermatomes. an emerging theory suggests that espb's clinical analgesia results from rapid and sustained local anesthetic (la) absorption from the injection site. as an alternative, intravenous la infusion (ivli) during the perioperative period may offer equivalent analgesia without the invasiveness of espb. iv lidocaine, known for its substantial analgesic properties, persists beyond its typical duration of action, likely through mechanisms beyond sodium channel blockade. although iv lidocaine has been established as part of multimodal analgesia in various perioperative settings, data specific to major bcs remain scarce. in this prospective, multicenter, randomized, triple-blind trial, the investigators aim to compare quality of recovery (assessed using the validated quality of recovery 15 \[qor15\] score) between usg espb and ivli. the investigator's hypothesis is that the quality of recovery after major breast cancer surgery with ivli will be comparable to that achieved with usg espb.

Eligibility criteria:
inclusion criteria: * asa i-iii patients * 18 to 75 years of age * patients scheduled for primary breast cancer surgery-mastectomy, modified radical mastectomy and breast conservation surgery with sentinel lymph node biopsy +/- axillary dissection will be included in this study. exclusion criteria: * patient refusal, * local skin site infection, * coagulopathy, * history of allergy to local anaesthetics, and * patients with hepatic, renal and cardiac dysfunction

Keywords: erector spinae plane block intravenous lidocaine infusion breast cancer surgery quality of recovery
thermal spread into the interstitial portion of the fallopian tubes using the ligasure device at time of hysterectomy

Conditions: Cervical Cancer; Ovarian Cancer; Uterine Cancer

Summary: some patients, specifically those with a diagnosed genetic mutation, will have their ovaries and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian and fallopian tube cancer from developing. anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries. the fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm of the uterine muscle wall. the purpose of this study is to determine if the technique used to remove fallopian tubes only (without removal of the uterus) adequately removes or destroys all the fallopian tube cells that remain in the uterine muscle wall. currently, during the operation an instrument is used that burns the fallopian tube and allows it to be cut away from the uterus. the investigators do not know if this procedure successfully destroys all the fallopian tube cells within the uterus. therefore, we will compare this single step procedure to a two step procedure. the two step procedure is to burn and cut the fallopian tube followed by an additional burning step, called cauterization at the top of the uterus. the investigators will assess if either or both of these procedures destroy the fallopian tube cells that may remain inside the uterine wall. this is important to determine since the goal is to remove the ovaries and all of the fallopian tubes in order to prevent future development of ovarian or fallopian tube cancer.


Eligibility criteria:
inclusion criteria: * women undergoing a non-emergent total hysterectomy with removal of the tubes and ovaries by the gynecologic service for benign or malignant conditions uterine, cervical or early ovarian cancer. * patients will undergo either a laparotomy, total laparoscopy or laparoscopically assisted vaginal hysterectomy * patients will be 21 years and older. exclusion criteria: * patients with abnormal fallopian tubes seen preoperatively by radiologic exam or intraoperatively by visual inspection. * patients who are suspected to have fallopian tube cancer prior to their surgery * patients who have had prior pelvic radiation therapy * patients who are undergoing a robotically assisted procedure * patients who have had any type of prior tubal surgery

Keywords: ovary uterus cervix 08-092
menopause and oral health

Conditions: Menopause; Periodontal Diseases

Summary: menopause is characterized by major physiological and concomitant psychological changes. the study aimed to evaluate the association between oral health parameters, bone mineral density (bmd) and physiological or psychological symptoms in post-menopausal women (pmw), compared with regularly menstruating women (rmw). inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. the participants were asked to complete the women's health questionnaire to measure emotional and physical well-being. a total of 148 women (pmw, n=76,rmw, n=72) received a comprehensive medical assessment and a full-mouth oral examination. the corresponding bone mineral density (bmd) and body mass indices (bmi) were obtained from their medical records.


Eligibility criteria:
inclusion criteria: * being 35-65 years of age * having history of spontaneous amenorrhea for the last 12 months for pmw. * lack of irregularity in menstrual cycles during the past 12 months for rmpw. * possessing at least 10 natural teeth without any prosthetic restoration exclusion criteria: * history of antibiotics use in last 3 months * ongoing cancer therapy * presence of oral ulcers or acute infectious disease * presence of diabetes mellitus
investigation of the glycemic index of ethiopian honey

Conditions: Hyperglycemia, Postprandial

Summary: the purpose of this study is to determine which of the ethiopian honeys slowly/rapidly raise the blood glucose level.

addis ababa university, college of natural sciences, research institutional review board (irb) approved this study. written consent forms were obtained from all 14 volunteers (7 females and 7 males). the subjects were randomly recruited from twenty eight 3rd year food science and postharvest technology students. people volunteering to participate in the study were excluded if they are: overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication. the participants were checked for glucose tolerance according to the who (world health organization) classification (fasting glucose \<7 mmol/l(millimole per lite) and 2-hour blood glucose concentration after a 25g glucose load \<7.8 mmol/l). ten (5 females and 5 males) were selected from fourteen using lottery sampling methods. reference glucose and monofloral honeys were used as experimental foods. to determine the gi value, 25 grams of available carbohydrate was fed for ten healthy people in the morning after they have fasted for 11 hours overnight. after fasting blood sample was obtained. the study participants were consumed each honey and reference glucose served. additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes after eating commenced. blood glucose response (area under the curve, auct) for test food was compared to the blood glucose response of reference glucose (aucr). auc was calculated using sas (statistical analysis software), 2002. glycemic index (gi) was calculated using: gi= auct/aucr\*100 where: auct = area under the curve for honey; aucr = area under the curve for the reference glucose

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes disease * must be able to drink the honeys and reference glucose exclusion criteria: * overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication.

Keywords: glycemic index honey reference glucose
neonatal cerebral oxygenation and changes in cpap flow pressure - evaluation with invos oximeter

Conditions: Cerebral Oxygenation

Summary: * due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. we will evaluate the capability of the invos oximeter to detect induced changes in the cerebral regional saturation. * the purpose of the study is to investigate our hypothesis that a particular cpap flow pressure optimizes the regional cerebral oxygenation.

preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. the preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. these conditions can affect the microcirculation and hence the oxygenation of the brain. hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. preterm infants is often treated with cpap (continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known. the investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (ga) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, cpap (continuous positive airway pressure). the investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the invos® cerebral/somatic oximeter (near infrared spectroscopy (nirs)). invos® is the first nirs-based oximeter ce-approved for hospital use in denmark. there will be no follow-up.

Eligibility criteria:
inclusion criteria: * inclusion criteria: - newborns with a gestational age of 32-40 weeks - clinically stable - +/- cpap with a oxygen limit below 30% - parental consent exclusion criteria: * severe birth asphyxia - prohibition of oxygen exposure

Keywords: preterm neonate newborn cerebral oxygenation cpap
clinical performance of investigational inrhythm pt/inr system in a professional use setting

Conditions: Blood Dyscrasia

Summary: this study is designed to evaluate and verify the clinical accuracy of the inrhythm pt/inr system; a point-of-care, whole blood pt/inr measurement with a reference plasma based pt/inr using a laboratory reference instrument and reagent (sysmex/lnnovin) calibrated to the who rtf09 reference standard.


Eligibility criteria:
inclusion criteria - all * the subjects must be \> 18 years of age. * the subjects must be willing and competent to sign an informed consent. * the subjects must be able to attend the clinic for one visit to donate one fs blood sample and one venous blood draw of approximately 10 cc. exclusion criteria - all * the subject is unable to donate fingerstick and venous blood samples. * the subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture. * the subject is enrolled in any other study that involves an investigational drug and/or device. additional inclusion criteria - therapeutic group * the subject must require oral vka anticoagulant therapy. * the patient must have been anticoagulated for at least three months prior to enrollment. additional exclusion criteria - normal group - subjects receiving any form of anticoagulation drugs such as aspirin or clopidogrel.
marrow mesenchymal cell therapy for osteogenesis imperfecta: a pilot study

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta (oi) is a genetic disease for which there is currently no known cure. oi causes the osteoblasts (bone-forming cells in the body) to grow poorly, which slows the growth of children with the disease and causes their bones to bend and break easily. some forms of osteogenesis imperfecta may cause severe disability and even death. in previous research studies performed at st. jude, it was found that children treated with bone marrow transplant (infusion of healthy immature blood-forming cells) began to grow faster, had more minerals (material that helps make the bones strong) in their bones, and broke their bones less often than before the bone marrow transplant. several months after the bone marrow transplant however, body growth once again began to slow down. in this research study, children with osteogenesis imperfecta will receive another infusion of bone marrow cells but without any chemotherapy. the marrow cells will come from the same bone marrow donor as their previous bone marrow transplant. it is hoped that by removing the cd3+ cells (a type of white blood cells that attack other cells that are not like themselves) from the donated bone marrow, the subject's body will be infused quite safely and that body growth and bone strength will increase. the cd3+ cells will be removed from the donor bone marrow by use of a machine called the clinimacs system. this machine has not been approved for use in the united states by the food and drug administration (fda). the use of this device is considered experimental.


Eligibility criteria:
inclusion criteria: * must have been previously enrolled on toit protocol at st. jude children's research hospital * must have original bone marrow donor available and willing to participate as a donor * normal liver function * hemoglobin \>10gm/dl

Keywords: collagen disease
stroke prevention and rhythm control therapy steeer-af

Conditions: Atrial Fibrillation

Summary: a prospective trial with hospitals/health centres across 6 different european countries, being randomised to either a structured education programme as the intervention or no additional education as the control. to determine whether a comprehensive educational programme for healthcare professionals will increase the rate of appropriate stroke prevention and rhythm control therapy in patients with atrial fibrillation (af) and adherence to guidelines.

prospective, parallel group, two-arm, unblinded, international, cluster-randomized controlled trial. intervention arm: a 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions control arm: no added education of healthcare professionals 70 centres with a cluster size of 25 patients; total estimated number of patients 1750. 8-12 weeks patient recruitment period at each centre; 16 weeks educational intervention period; primary \& secondary outcomes at 6-9 months post-randomisation; remote follow-up for clinical events (no new patient contact) at 18 months from randomisation.

Eligibility criteria:
inclusion criteria: * patients diagnosed with af * patient consents to data collection at baseline and follow-up. exclusion criteria (patients only): * patients aged under 18 years of age, * pregnant or planning pregnancy, * participating in another clinical trial of an investigational medicinal product or device, * life expectancy of less than 2 years. patient assessment: baseline (time of recruitment) and at follow-up routine appointment (6-9 months), plus remote follow-up at 18 months.

Keywords: atrial fibrillation guideline adherence stroke prevention rhythm control trial
efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

the study is divided into a core part and extension part. the core part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with multiple sclerosis (ms). the extension part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the core part of the study and meet all inclusion/exclusion criteria. the targeted enrollment is 120 participants with multiple sclerosis which will include at least 5 participants with body weight (bw) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. there is a minimum 6 month follow up period for all participants (core and extension). total duration of the study could be up to 7 years.

Eligibility criteria:
inclusion criteria: 1. between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization 2. diagnosis of multiple sclerosis 3. edss score of 0 to 5.5, inclusive 4. at least one ms relapse/attack during the previous year or two ms relapses in the previous two years prior or evidence of one or more new t2 lesions within 12 months exclusion criteria: 1. participants with progressive ms 2. participants with an active, chronic disease of the immune system other than ms 3. participants meeting the definition of adem 4. participants with severe cardiac disease or significant findings on the screening ecg. 5. participants with severe renal insufficiency

Keywords: relapsing multiple sclerosis pediatric relapse edss ofatumumab siponimod fingolimod rms ms